FDA applicant
Neusoft Medical Systems Co., Ltd.
FDA records 23 decisions for Neusoft Medical Systems Co., Ltd. (Shenyang, Liaoning, CN) from 2006 to 2023: 23 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 227 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 11 of them its own earlier devices. 20 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neusoft Medical Systems Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Neusoft Medical Systems Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Neusoft”
FDA records each applicant name separately; these may or may not be the same firm.